Abstract:
: Orally disintegrating tablet (ODT) is a friendly dosage form that requires no access to water and serves as a
solution to non-compliance. There are many co-processed adjuvants available in the market. However, there is no single
product possesses all the ideal characteristics such as good compressibility, fast disintegration and good palatability for
ODT application. The aim of this research was to produce a xylitol-starch base co-processed adjuvant which is suitable
for ODT application. Two processing methods namely wet granulation and freeze drying were used to compare the
characteristics of co-processed adjuvant comprising of xylitol, starch and crospovidone XL-10 mixed at various ratios.
The co-processed excipients were compressed into ODT and physically characterized for powder flow, particle size,
hardness, thickness, weight, friability, in-vitro disintegration time and in-situ disintegration time, lubricant sensitivity,
dilution potential, Fourier transform infrared spectroscopy, scanning electronic microscopy and x-ray diffraction
analysis. Formulation F6 was selected as the optimum formulation due to the fastest in-vitro (135.33±11.52 s) and in-situ
disintegration time (88.67±13.56s) among all the formulations (p<0.05). Increase in starch component decreases
disintegration time of ODT. The powder flow fell under the category of fair flow. Generally, it was observed that freeze
drying method produced smaller particle size granules compared to wet granulation method. ODT produced from freeze
drying method had shorter disintegration time compared to ODT from wet granulation batch. In conclusion, a novel coprocessed excipient comprised of xylitol, starch and crospovidone XL-10, produced using freeze drying method with fast
disintegration time, good compressibility and palatability was developed and characterized. The co-processed excipient
is suitable for ODT application.
